Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04700371
Status:
WITHDRAWN
Last Update Posted:
2024-03-12
First Post:
2021-01-04
Brief Title:
Vessel Deformations and Restenosis After Stenting of the Popliteal Artery
Sponsor:
Kantonsspital Aarau
Organization:
Kantonsspital Aarau
Study Overview
Official Title:
Flexion-Induced Vessel Deformations and Restenosis After Stenting of the Popliteal Artery
Status:
WITHDRAWN
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of financial support
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIRESTEP
Brief Summary:
The femoro-popliteal FP artery is the most frequently treated vascular segment in patients with symptomatic peripheral artery disease PAD for which endovascular therapy became an established treatment option during the last decades However loss of primary patency and consecutive clinically driven target lesion revascularization TLR limit this procedure Moreover in the popliteal artery PA evidence about the best treatment strategy to prevent loss of patency and TLR is limited to only a few randomized controlled trials RCT Arterial deformations of the PA with its unique anatomical properties during leg flexion might explain the poor technical and clinical outcomes in this segment Generally a leave nothing behind strategy in the PA is preferred but cannot be avoided in all cases due to eg flow limiting dissections or re-coil after balloon angioplasty Basically two different self-expandable nitinol-based stent designs are available on the market An interwoven nitinol and laser-cut nitinol stent The interwoven nitinol stent has a higher radial force in comparison to the laser-cut stent and reveals higher patency rates in the FP arteries However a head-to-head comparison of these stents is missing and it remains unknown in which way different stent designs affect the deformation and hemodynamic behaviors of the PA during knee flexion
Detailed Description:
Randomized trial to investigate the impact of different stent designs on the target lesion restenosis rate in femoro-popliteal arteries Immediately after stent implantation sets of three orthogonal angiographic views separated by an angle of 25 of the stented region TL will be obtained with the leg in supine position This will be followed by intra-arterial imaging using Optical Coherence Tomography OCT OCT images one pullback if the lesion length is 75 mm 2 pullbacks otherwise of the TL will be acquired using the Dragonfly catheter In addition duplex ultrasound DU of the TL will be performed including the arterial segments 10cm at proximal and distal edge of the TL Thereafter a bending cast will be used to obtain a kneehip flexion of approximately 7020 In this position the angiographic OCT and DU measurements will be repeated
The OCT images will provide the shapes of the arterial lumen which will be used to generate 3D surface models in stl format The X-ray images will be utilized to construct the 3D arterial centerline for the supine and flexed leg positions These arterial centerlines will be used to quantify the axial deformation in mm twisting in and curvature changes in mm-1 along the length of the investigated segment Additionally the lumen profiles obtained from OCT images will be used to accurately estimate the radial deformations in mm in the lumen and define instances of arterial pinching during leg flexion as the difference in lumen diameters between straight and flexed leg positions
The geometries of the arterial lumens will be combined with their corresponding 3D arterial centerlines to generate patient-specific arterial models Along with patient-specific boundary conditions obtained from DU measurements these models will be transferred to a commercial software to perform Computational Fluid Dynamics analyses The changes in these parameters due to leg flexion as well as due to different stent designs will be quantified
The OCT images will provide the shapes of the arterial lumen which will be used to generate 3D surface models in stl format The X-ray images will be utilized to construct the 3D arterial centerline for the supine and flexed leg positions These arterial centerlines will be used to quantify the axial deformation in mm twisting in and curvature changes in mm-1 along the length of the investigated segment Additionally the lumen profiles obtained from OCT images will be used to accurately estimate the radial deformations in mm in the lumen and define instances of arterial pinching during leg flexion as the difference in lumen diameters between straight and flexed leg positions
The geometries of the arterial lumens will be combined with their corresponding 3D arterial centerlines to generate patient-specific arterial models Along with patient-specific boundary conditions obtained from DU measurements these models will be transferred to a commercial software to perform Computational Fluid Dynamics analyses The changes in these parameters due to leg flexion as well as due to different stent designs will be quantified
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None